This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

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Rules and Regulations Federal Register

67239 

Vol. 77, No. 218 

Friday, November 9, 2012 

1U.S. Department of Agriculture, Office of 

Inspector General, Audit Report 01601–03-Hy, 

March 2010. Available at http://www.usda.gov/oig/ 

webdocs/01601-03-HY.pdf. 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 205 

[Document Number AMS–NOP–10–0102; 

NOP–10–10FR] 

RIN 0581–AD10 

National Organic Program; Periodic 

Residue Testing 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: This final rule clarifies a 

provision of the Organic Foods 

Production Act of 1990 and the 

regulations issued thereunder that 

requires periodic residue testing of 

organically produced agricultural 

products by accredited certifying agents. 

The final rule amends the U.S. 

Department of Agriculture’s (USDA) 

National Organic Program (NOP) 

regulations to make clear that accredited 

certifying agents must conduct periodic 

residue testing of agricultural products 

that are to be sold, labeled, or 

represented as ‘‘100 percent organic,’’ 

‘‘organic,’’ or ‘‘made with organic 

(specified ingredients or food 

group(s)).’’ The final rule expands the 

amount of residue testing of organically 

produced agricultural products by 

clarifying that sampling and testing are 

required on a regular basis. The final 

rule requires that certifying agents, on 

an annual basis, sample and conduct 

residue testing from a minimum of five 

percent of the operations that they 

certify. This action will help further 

ensure the integrity of products 

produced and handled under the NOP 

regulations. 

DATES: Effective Date: This final rule is 

effective January 1, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Melissa R. Bailey, Ph.D., Director, 

Standards Division, Telephone: (202) 

720–3252; Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 6511 of the Organic 

Foods Production Act of 1990 (OFPA), 

as amended, (7 U.S.C. 6501–6522), the 

National Organic Program (NOP) is 

authorized to implement regulations 

that require accredited certifying agents 

to conduct residue testing of organically 

produced agricultural products. Section 

6506 of the OFPA also requires that the 

NOP include provisions for periodic 

residue testing by certifying agents of 

agricultural products produced or 

handled in accordance with the NOP. 

Residue testing plays an important 

role in organic certification by providing 

a means for monitoring compliance with 

the NOP and by discouraging the 

mislabeling of agricultural products. 

Testing of organically produced 

agricultural products is promulgated in 

section 205.670 of the NOP regulations 

(7 CFR part 205). This section provides 

that the Secretary, State organic 

programs, and certifying agents may 

require preharvest or postharvest testing 

of any agricultural input used or 

agricultural product to be sold, labeled, 

or represented as ‘‘100 percent organic,’’ 

‘‘organic,’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’ 

when there is reason to believe that the 

agricultural input or product has come 

into contact with a prohibited substance 

or has been produced using excluded 

methods. 

The Agricultural Marketing Service 

(AMS) is issuing this final rule in 

response to an audit of the NOP which 

was conducted in March 2010 by the 

USDA Office of Inspector General 

(OIG).1 As part of the audit, the OIG 

visited four certifying agents accredited 

by the NOP. The audit found that none 

of the four certifying agents visited 

conducted periodic residue testing. The 

OIG indicated that these certifying 

agents noted that they considered 

residue testing to be required by the 

regulations only under certain 

circumstances. 

AMS conducted a review of this issue 

in response to the OIG audit. AMS 

concluded that, under section 6506 of 

the OFPA, accredited certifying agents 

are required to conduct residue testing 

of organic products on a regular and 

reoccurring basis, as well as when there 

is reason to believe contamination has 

occurred, and that the regulations be 

revised as provided for in this 

rulemaking. 

On June 23 and June 24, 2010, the 

NOP conducted two webinar trainings 

with certifying agents on periodic 

residue testing under the NOP. The 

objective of the webinar was to present 

an overview of requirements for 

periodic residue testing under the OFPA 

and the NOP. The NOP also solicited 

feedback from the certifying agents who 

participated in the webinar. Of the 

certifying agents accredited at that time, 

55 individuals registered to participate 

in the webinar. Ten participants in the 

webinar provided written feedback to 

the NOP in response to the information 

provided. These comments were 

considered in the development of this 

final rule. 

On April 29, 2011, AMS published a 

proposed rule for periodic residue 

testing (76 FR 23914). The rule 

proposed that certifying agents, on an 

annual basis, must sample and conduct 

residue testing from a minimum of five 

percent of the operations that they 

certify. The proposed rule included a 60 

day comment period. Comments were 

also specifically requested on the 

information collection burden that 

would result from the proposed action. 

The NOP received over 30 written 

comments in response to the proposed 

rule. 

II. Comments on Proposed Rule 

Comments in response to the 

proposed rule were received from 

certified organic operations, certifying 

agents, consumers, trade associations, 

organic associations, and various 

industry groups. 

The majority of commenters 

supported residue testing in general, 

and offered comments regarding the role 

of the National Organic Standards Board 

(NOSB), sampling rates, sample 

selection, costs and costs estimates, 

testing methodology, data collection, 

and reporting requirements. 

Four comments specifically addressed 

the information collection and 

recordkeeping requirements of this 

action pursuant to the Paperwork 

Reduction Act (44 U.S.C. 3501–3520) 

(PRA). 


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67240 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 

2U.S. Senate, Committee on Agriculture, 

Nutrition, and Forestry. Food, Agriculture, 

Conservation, and Trade Act of 1990, S. Rpt. 101– 

357 to accompany S. 2830, July 6, 1990. 

3National Organic Standards Board, Final 

Recommendations, Residue Testing, 1994. 

Available on the NOP Web site at http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=stelprdc5058863. 

AMS received one comment from a 

certifying agent requesting an extension 

of the comment period. Since the 

proposed rule included a 60 day 

comment period and because the NOP 

previously conducted two webinar 

trainings with certifying agents on 

periodic residue testing on June 23 and 

June 24, 2010, we did not agree that an 

extension of the comment period was 

warranted. 

Authority To Issue Rule 

Seven commenters indicated that they 

did not believe that AMS has the 

authority to issue a rule on residue 

testing under the OFPA without a 

recommendation from the NOSB. 

The NOSB is a federal advisory 

committee established by the Secretary 

of Agriculture under section 6518 of the 

OFPA to assist in the development of 

standards for substances to be used in 

organic production and to advise the 

Secretary on other aspects of the 

implementation of the NOP. 

The commenters cited section 6518 of 

the OFPA which states ‘‘the Board shall 

advise the Secretary concerning the 

testing of organically produced 

agricultural products for residues 

caused by unavoidable residual 

environmental contamination.’’ 

Additionally, two commenters cited a 

1990 report of the U.S. Senate 

Committee on Agriculture, Nutrition, 

and Forestry, which indicates that the 

NOSB would be most knowledgeable on 

the subject of levels of acceptable 

residues of prohibited materials for 

organic food, and that the Committee 

intends that the NOSB shall advise the 

Secretary concerning appropriate 

residue levels and testing methods for 

organic products.2

AMS disagrees with the commenters’ 

claims that AMS does not have the 

authority to issue a rule in this area. 

This final rule is issued under the 

authority of the OFPA at section 

6506(a)(6) which requires periodic 

residue testing by certifying agents. This 

rule does not amend any provisions or 

thresholds related to the maximum 

allowable pesticide residue for organic 

food or thresholds related to 

unavoidable residual environmental 

contamination (UREC). The existing 

NOP regulations regarding UREC at 

section 205.671 were based on a 

recommendation adopted by the NOSB 

at its meeting June 1–4, 1994 in Santa 

Fe, New Mexico.3 UREC is defined 

under section 205.2 of the NOP 

regulations as background levels of 

naturally occurring or synthetic 

chemicals that are present in the soil or 

present in organically produced 

agricultural products that are below 

established tolerances. This rule does 

not amend this existing definition. 

Number of Samples 

AMS received twelve comments on 

the issue of the amount of sampling or 

number of samples. The proposed rule 

indicated that certifying agents would 

be required, on an annual basis, to 

sample and conduct residue testing 

from a minimum of five percent of the 

operations that they certify. The 

proposed rule indicated that residue 

testing conducted for causative reasons, 

such as complaint-driven testing, or 

testing when there was reason to 

suspect contamination, would not be 

counted towards the minimum 

percentage required. 

Based on the comments received, 

AMS believes that using a percentage of 

certified operations to determine sample 

selection offers the simplest 

implementation for certifying agents 

and ensures that all certifying agents 

conduct a minimal level of residue 

testing. Further discussion of the 

comments received is provided below. 

Number of Samples—Changes Based on 

Comments 

AMS received five comments 

requesting that all residue testing 

conducted by a certifying agent be 

counted towards the five percent 

minimum requirement, including 

compliance testing, investigative testing, 

risk-based sampling, and random 

sampling. One commenter indicated 

that establishing random testing at five 

percent would make it more difficult to 

do other types of testing (e.g. risk-based, 

compliance testing) because of the costs 

involved. Several commenters indicated 

that compliance, investigative, and riskbased testing would yield more 

meaningful results than random testing. 

One comment from a certifying agent 

indicated that it did not support 

revising the rule to include compliance 

or investigative testing as part of the five 

percent requirement. Based on 

experience in taking samples for both 

purposes, the commenter indicated that 

the concern from certifying agents that 

the proposed rule would be a 

disincentive to conduct compliance or 

investigative testing was unfounded. 

The NOP accepts the majority of the 

commenters’ suggestions to include all 

testing towards the minimum 

requirement. Any residue testing 

performed by a certifying agent may be 

counted towards the minimum 

requirement for residue testing, 

provided that the certifying agent 

samples and tests from a minimum of 

five percent of the operations it certifies 

on an annual basis. 

AMS received two comments 

requesting a phase-in period for the 

testing requirements. One commenter 

suggested testing a portion of the five 

percent minimum percentage of 

operations in 2012, and the full 

percentage of operations in 2013. The 

commenter noted that a phase-in would 

enable certification agents to plan 

budgets, develop office procedures, and 

train staff and inspectors. The 

commenter also noted that a phase-in 

would enable the NOP to assess the 

effectiveness of the testing program. 

AMS received one comment requesting 

a phase-in of three percent for the first 

two years, which could be reevaluated 

and adjusted accordingly in the future. 

AMS has considered the commenters’ 

suggestion for a phase-in of the 

implementation and compliance date of 

the final rule and has issued this final 

rule with an effective date of January 1, 

2013. Certifying agents must be fully 

compliant with the five percent 

requirement for the 2013 calendar year. 

The NOP understands that a minority of 

accredited certifying agents currently 

conduct residue testing on a regular, 

periodic basis. However, the NOP notes 

that certifying agents are already 

required, under section 205.504(b)(6) of 

the NOP regulations, to have procedures 

and trained staff in place for 

investigations of pesticide drift, 

complaints, or when reason to believe a 

product has come into contact with a 

prohibited substances. As evidence of 

their expertise and ability, certifying 

agents are also already required to 

submit a copy of the procedures to be 

used for sampling and residue testing 

pursuant to section 205.670 as an 

accreditation requirement. 

Number of Samples—Changes 

Requested But Not Made 

One commenter noted that the 

number of operations that would be 

sampled under the proposed rule was 

small relative to the total number of 

operations. The commenter noted that 

sampling based on the number of 

operations does not account for 

differences in sizes of the operations, 

and suggested that sampling be based 

upon size and quantity, rather than the 

number of operations. The commenter 


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Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 67241 

suggested that AMS have an unbiased 

group determine sampling methodology 

using proper scientific and statistical 

techniques. The commenter noted that, 

unless AMS uses a sound basis in 

choosing the number, size, and site of 

the samples, any conclusions drawn 

from the testing would be invalid. 

Another commenter suggested that 

AMS should require sampling based on 

a percentage of products, rather than a 

percentage of operations. 

Two comments indicated that the five 

percent number was arbitrary and not 

statistically valid, but did not offer an 

alternative method for determining 

sampling size. 

AMS disagrees. Basing sampling on a 

percentage of operations reduces the 

burden on the certifying agents by 

providing a clear and simple formula for 

how to comply with the regulations. 

The five percent requirement satisfies 

AMS’s intent to discourage the 

mislabeling of agricultural products and 

provide a means for monitoring 

compliance with the NOP. 

Under the final rule, certifying agents 

have the discretion to select operations 

for residue testing based on criteria such 

as size of operation, quantity of 

products produced, previous 

compliance issues, or other risk factors. 

Certifying agents are knowledgeable 

about the risk factors affecting the 

operations it certifies; therefore, it is 

appropriate for a certifying agent to 

determine what operations should be 

tested under this action. 

AMS received three comments 

requesting that AMS lower the 

minimum percentage of operations to be 

tested from five percent to three percent 

due to costs. One of the commenters 

stated that the costs of testing would be 

passed on indirectly to farmers and 

processors in the form of higher 

certification fees. Another commenter 

stated that requiring three percent, 

rather than five percent, would allow 

the certifying agent more latitude for 

doing risk-based and compliance 

sampling. 

In the final rule, AMS allows for both 

periodic testing and compliance 

sampling to be counted towards the 

minimum requirement, but has retained 

the minimum percentage of operations 

to be tested at five percent annually. 

AMS has considered the comment 

that this action may indirectly increase 

costs to certified operations if certifying 

agents increase their certification fees to 

recover costs from increased residue 

testing. This action implements periodic 

residue testing in a way that should 

minimize the direct costs to certifying 

agents and any indirect costs to certified 

operations while still meeting the 

objectives of implementing periodic 

residue testing as required by OFPA. 

Additional details on the costs, benefits, 

and alternatives considered are 

discussed in the section titled Executive 

Order 12866 and Executive Order 

13563. 

AMS notes that lowering the 

percentage below five percent does not 

have an impact on the smallest quartile 

of certifying agents that certify fewer 

than thirty operations to the NOP per 

year, since they are required to sample 

a minimum of one operation under 

either scenario. 

One comment from a consumer group 

indicated that AMS should reserve the 

right to raise the percentage for a 

specific certifying agent if residue 

testing shows that a certifying agent has 

an unusually high number of positive 

results. AMS believes that the 

regulations provide sufficient flexibility 

for the NOP to address issues that may 

arise on a case-by-case basis, and 

therefore, no modifications are 

necessary to the regulations. 

One commenter requested that AMS 

review the residue testing data in five 

years to see if the percentage of 

operations tested could be reduced. 

AMS notes that the final rule does not 

prohibit AMS from reconsidering the 

percentage of operations required for 

compliance at a later date based on new 

information, but this would be under a 

separate rulemaking action. 

AMS received one comment from a 

certifying agent regarding the role of 

State organic programs under the 

proposed rule. AMS currently has one 

State organic program in California. The 

commenter requested that testing 

conducted by a State program should 

offset the certifying agents’ requirement 

in that State. AMS disagrees. Under the 

OFPA, certifying agents are required to 

conduct residue testing. AMS believes 

that requiring certifying agents to test 

from five percent of certified operations 

on an annual basis is reasonable, and 

that testing conducted by other 

organizations, including State organic 

programs or other private testing 

programs, should not offset this 

requirement under the OFPA. 

Operation Selection and Conflict of 

Interest—Changes Requested But Not 

Made 

AMS received nine comments 

regarding the selection of operations for 

residue testing. Several commenters 

requested clarification on selection of 

operations and whether it is AMS’ 

intent to have certifying agents select 

operations at random or use other 

criteria. It is not AMS’ intent for this 

final rule to require certifying agents to 

select operations at random. AMS is not 

specifying how certifying agents should 

select operations for residue testing in 

order to provide flexibility to the 

certifying agency. Instead, AMS is 

providing discretion to the certifying 

agent to select operations. Operation 

selection for residue testing may include 

risk factors such as number of products 

produced, split operations, size of the 

operation, high-value or high-risk crops, 

or other criteria deemed appropriate by 

the certifying agent. 

Three commenters indicated that 

certifying agents should not select the 

operations for residue testing since this 

may be an inherent conflict of interest. 

Commenters suggested that the NOP or 

other third-party groups select the 

operations. AMS disagrees. Certifying 

agents are already required to 

implement procedures to prevent 

conflict of interests as a condition of 

accreditation under the NOP regulations 

(§ 205.501(a)(11)). AMS also conducts 

regular audits of certifying agents to 

ensure compliance with NOP 

accreditation requirements including 

preventing conflicts of interest. AMS 

does not have reason to believe that 

selection of operations for purposes of 

periodic residue testing would be 

different from any other certification 

work carried out by certifying agents 

with respect to conflict of interest. 

Several commenters suggested 

utilizing a system of statistical sampling 

methods for operation selection, such as 

that used by the AMS Pesticide Data 

Program. AMS disagrees. It is not AMS’ 

intent to assemble data and draw 

conclusions based on statistical 

sampling techniques, as the sampling 

performed by certifying agents will vary 

considerably due to the worldwide 

diversity of operations which are 

certified to the NOP. Certifying agents 

have the discretion to sample from 

higher risk operations, which may yield 

results that are not representative of all 

organic operations. 

Types of Samples—Changes Based on 

Comments 

AMS received eight comments 

regarding the selection of samples for 

residue testing. The commenters 

requested changes in the rule to clarify 

that residue sampling may be performed 

on samples which are not finished 

products, such as soil samples, tissue 

samples, or water. 

Commenters noted that preharvest 

sampling may be more meaningful 

when sampling is risk-based or for 

investigative testing (e.g., when use of a 

prohibited substance is suspected). In 

addition, commenters suggested that 

preharvest testing of tissue samples, 


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4NOP Policy Memo 11–6, Reporting Health & 

Safety Violations, revised October 31, 2011. 

Available at http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5088951. 

soil, or water may be more appropriate 

at certain times during the growing 

season. 

AMS agrees with the commenters’ 

suggestions and has amended the 

regulatory text accordingly to clarify 

that testing may be conducted 

preharvest or postharvest, and that 

residue testing is not limited to salable 

products only. The final rule specifies 

the types of materials for sampling that 

are currently listed in section 

205.403(c)(3) for on-site inspections. 

This may include collection and testing 

of soil; water; waste; seeds; plant tissue; 

and plant, animal, and processed 

products samples. AMS notes that, in 

the case of pesticide residue testing, 

tolerances are established by the 

Environmental Protection Agency (EPA) 

for specific harvested commodities. 

These tolerances enable the certifying 

agent to take appropriate enforcement 

action, if warranted, for the harvested 

commodity. If a prohibited residue is 

detected in a sample where there is not 

an established tolerance, such as soil, 

water, or other plant tissues, follow-up 

testing of the harvestable product may 

be needed for the certifying agent to 

determine the appropriate enforcement 

action. 

Additionally, AMS notes that 

certifying agents currently have the 

authority to collect samples under 

section 205.403(c) which states that 

‘‘The on-site inspection of an operation 

must verify: (3) That prohibited 

substances have not been and are not 

being applied to the operation through 

means which, at the discretion of the 

certifying agent, may include the 

collection and testing of soil; water; 

waste; seeds; plant tissue; and plant, 

animal, and processed products 

samples.’’ 

Types of Samples—Changes Requested 

But Not Made 

AMS received one comment 

requesting that processed products 

which are to be sold or labeled as 

‘‘organic’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’ 

be excluded from residue testing 

requirements. The commenter states 

that testing would not pinpoint the 

source of contaminants in processed, 

multi-ingredient products. In certain 

cases, the source of a residue detected 

in a multi-ingredient processed product 

may be more difficult to identify; 

however, we have retained the 

allowance for testing processed 

products to allow certifying agents the 

flexibility of sampling processed 

products when it may be useful to 

determine compliance with the 

regulations. 

Reporting Requirements 

AMS received eight comments 

regarding reporting requirements. 

Several commenters requested 

clarification on the use of the term 

‘‘promptly’’ in reporting results to the 

AMS Administrator (Administrator). 

The proposed rule did not specify a 

reporting time period and retained the 

term ‘‘promptly’’ from the existing NOP 

requirements at section 205.670. 

Several commenters also requested a 

distinction between reporting violative 

versus non-violative sample results. The 

commenters suggested that violative 

samples (i.e., samples with residues 

detected) could be reported to the 

Administrator as the information was 

received, but requested that nonviolative samples (i.e., where no 

residues are detected) be reported on a 

more infrequent basis, such as quarterly 

or annually. One commenter requested 

that reporting be required on at least an 

annual basis, but not more than twice 

annually. Two commenters requested 

that the NOP require all results to be 

reported and incorporated into a dataset 

that would be available to the public. 

After further consideration, AMS has 

amended the reporting requirements 

required under section 205.670 in order 

to reduce the reporting burden on 

certifying agents. This rule eliminates 

the requirement that certifying agents 

must submit all residue testing results to 

the Administrator or State organic 

program’s governing State official. AMS 

does not intend to consolidate residue 

testing data from certifying agents and 

does not need reporting of residue 

testing results as the mechanism to 

ensure that certifying agents are meeting 

the requirement periodic residue 

testing. 

AMS intends to verify compliance of 

certifying agents with the requirements 

for periodic residue testing as part of the 

existing accreditation process. 

Accreditation requirements at section 

205.504(b)(6) require certifying agents to 

have administrative policies and 

procedures, including procedures to be 

used for sampling and residue testing 

pursuant to § 205.670. Certifying agents 

are also required to submit an annual 

report to the Administrator on or before 

the anniversary date of the issuance of 

notification of accreditation which 

includes a complete and accurate 

update of information submitted 

pursuant to §§ 205.503 and 205.504. In 

order to verify that certifying agents are 

implementing this rule in advance of 

regularly scheduled on-site audits, AMS 

intends to require, as authorized under 

section 205.510(a)(3), certifying agents 

to submit in their next annual report a 

description of the measures 

implemented in the previous year and 

any measures to be implemented in the 

coming years to meet the requirements 

in this rule for periodic residue testing. 

In addition, AMS notes that certifying 

agents should continue to maintain the 

complete results of laboratory analyses 

for residues of pesticides and other 

prohibited substances conducted during 

the current and three preceding 

calendar years, as required by section 

205.504(b)(5)(iii). 

The final rule also clarifies the 

reporting requirements when test results 

indicate that a specific agricultural 

product contains pesticide residues or 

environmental contaminates that exceed 

the Food and Drug Administration’s 

(FDA) or EPA’s regulatory tolerances. 

Under section 6506 of the OFPA, 

certifying agents, to the extent that they 

are aware of a violation of applicable 

laws relating to food safety, are required 

to report such violation to the 

appropriate health agencies. This is 

promulgated in section 205.670(e), 

amended by this final rule at 205.670(g), 

of the NOP regulations, which requires 

reporting to the Federal health agency 

whose regulatory tolerance or action 

level has been exceeded. The NOP 

issued a policy memo on reporting 

health and safety violations to 

stakeholders and interested parties.4

This final rule clarifies the reporting 

requirements at 205.670(g), but does not 

change the responsibility for reporting 

by certifying agents when residues are 

found in excess of federal regulatory 

tolerances established by EPA or FDA. 

The final rule indicates that certain 

residue testing results that are in 

violation of EPA or FDA requirements 

must be reported to the appropriate 

State health agency or foreign 

equivalent. This change in the 

regulations is intended to recognize the 

role of State agencies, or their foreign 

equivalents, in responding to residues 

in violation of tolerance requirements. 

One comment from a certifying agent 

that operates outside of the United 

States indicated that reporting test 

results that exceed federal regulatory 

tolerances is under the operator’s 

responsibility. The commenter 

indicated that, as a certifying agent, it 

would check to make sure reporting was 

done correctly by the operation, and 

that the certifying agent would inform 

the NOP. AMS disagrees. Under the 

OFPA (7 U.S.C. 6506), certifying agents, 

to the extent that they are aware of a 


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Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 67243 

violation of applicable laws relating to 

food safety, are required to report such 

violation to the appropriate health 

agencies. This requirement is 

promulgated at section 205.670 of the 

regulations. This final rule clarifies the 

reporting requirements, but does not 

change the responsibility for reporting 

by certifying agents. 

In addition to the reporting 

requirements outlined in the final rule, 

the NOP published, on June 13, 2011 in 

the Federal Register (76 FR 34180), the 

availability of draft guidance entitled, 

NOP 5028—Responding to Results from 

Pesticide Residue Testing, that outlines 

the actions to be taken by accredited 

certifying agents if test results from 

residue analysis show evidence of 

prohibited substance(s) in or on the 

product. The notice included a 60-day 

comment period, which closed on 

August 12, 2011. After review of the 

comments received, the NOP intends to 

publish final guidance on this issue in 

the NOP Handbook, as described under 

Related Documents. Under section 

205.671, when residue testing detects 

prohibited substances that are greater 

than five percent of the EPA’s tolerance 

for the specific residue detected or 

unavoidable residual environmental 

contamination, the agricultural product 

must not be sold, labeled, or represented 

as organically produced. This final rule 

does not change this existing 

requirement. The draft guidance 

document provides information to 

certifying agents on how to respond to 

results that indicate residues of 

prohibited substances and how to report 

results that are in violation of FDA or 

EPA’s regulatory tolerances as required 

by section 205.670(g). 

Wild Crops—Changes Requested But 

Not Made 

AMS received one comment from a 

certified operation regarding the testing 

of wild crops. The commenter requested 

an exemption from the requirement for 

periodic residue testing for wild crops 

on the basis that EPA tolerances are not 

established for most herbs in commerce. 

The commenter suggests that the 

absence of established tolerances places 

wild crops at disproportionate risk of 

enforcement actions as a result of the 

detection of trace amounts of 

unavoidable contamination (e.g., drift) 

of unknown origin. AMS disagrees. One 

of the purposes of periodic residue 

testing is to provide a means for 

monitoring compliance with the NOP by 

discouraging the mislabeling of 

agricultural products. AMS has 

determined that all crops should be 

included within the scope of periodic 

residue testing to serve as a deterrent for 

mislabeling (e.g., to deter substitution of 

conventionally produced herbs for 

organic wild-crop harvested herbs). 

The commenter also requested written 

clarification as to how unavoidable 

pesticide residue contamination of wild 

crops would be addressed under the 

regulation in the absence of EPAestablished tolerances for most plant 

species. A clarification is included in 

the draft guidance NOP 5028— 

Responding to Results from Pesticide 

Residue Testing, as described below 

under Related Documents. 

International Trade 

AMS received one comment from an 

organic industry group in Canada which 

opposed the proposed rule. The 

commenter stated that the United States 

and Canada are currently signatories to 

an equivalency determination for 

organic products, and that the 

imposition of a costly measure on the 

United States’ side, without a 

corresponding rule in Canada, could 

lead the identification of this regulatory 

change as a critical variance which 

would impede trade. Residue testing is 

required under the European Union’s 

(EU) organic standards and, in 2011, 

Canada and the EU signed an organic 

equivalency determination that does not 

include any critical variances related to 

residue testing. In addition, certifying 

agents accredited under the NOP must 

already conduct sampling and 

laboratory testing in instances where 

contamination is suspected under 

sections 205.403(c)(3) and 205.670(b). 

AMS does not anticipate that this 

requirement for periodic residue testing 

will impact the United States’ 

equivalency determination with Canada. 

Costs and Cost Estimates—Changes 

Requested But Not Made 

AMS received eighteen comments 

regarding estimates of the costs of 

testing. In the proposed rule, AMS had 

estimated the cost at $500 per sample, 

and estimated that the costs may 

represent approximately 1% of a 

certifying agent’s operating budget. 

Several commenters stated their belief 

that residue testing at the certifying 

agent’s own expense was a disincentive 

to residue testing, and that the OFPA 

did not directly address who must pay 

for testing. A comment from a certifying 

agent who certifies operations to the 

organic standards of the EU, the 

Japanese Agricultural Standard (JAS), 

and the NOP, indicated that the 

regulations of the EU and JAS do not 

oblige the certifying agent to pay for 

pesticide analyses; instead, the cost is 

directly passed on to the operator. The 

commenter suggested that the NOP 

adopt this same approach and indicated 

that it encourages certifying agents to 

take the amount of samples which is 

necessary, and not just what is required 

by the regulations. Another commenter 

expressed support for this model. 

Section 205.670(b) currently provides 

that preharvest and postharvest testing 

is conducted at a certifying agent’s 

expense. Similar to that provision, it is 

reasonable that periodic residue testing 

also be conducted at the certifying 

agent’s expense, and therefore no 

changes are made to the final rule based 

on these comments. 

Several commenters requested a more 

thorough analysis of the costs of 

implementing periodic residue testing. 

A more detailed analysis of the costs 

associated with this action is provided 

under the section titled Executive Order 

12866 and Executive Order 13563. AMS 

notes that a minority of certifying agents 

currently conduct periodic residue 

testing at or above the minimum levels 

established by this final rule and there 

would be no additional costs associated 

with this action for those certifying 

agents. The majority of certifying agents, 

however, would need to allocate 

additional resources for the costs 

associated with periodic residue testing. 

AMS received one comment from a 

certifying agent operating outside of the 

United States which indicates that it 

currently tests 20–25% of its certified 

operations, which is above the 

minimum level specified in this final 

rule. 

One comment from a laboratory 

indicated that AMS’ estimated $500 cost 

for analysis was high by a factor of two 

or more, and that it may be able to 

perform this analysis for certifying 

agents at $250 per sample or less. The 

commenter’s estimate appears to be 

limited to the direct laboratory costs of 

residue analysis, and does not include 

the additional related costs that AMS 

has included in the estimated costs per 

sample. 

Several commenters indicated that the 

costs may disproportionally affect 

smaller certifying agents, since they 

would not be able to receive quantity 

discounts. Some laboratories may offer 

discounts to its higher-volume clients, 

including certifying agents. However, 

AMS also notes that lowering the 

percentage below five percent does not 

have an impact on the smallest quartile 

of certifying agents that certify fewer 

than thirty operations per year, since 

they are required to sample a minimum 

of one operation annually. 

One commenter suggested an 

alternative funding mechanism, such as 

having pesticide manufacturers and 

producers of genetically modified seed 


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5http://www.aoac.org/. 

pay for the costs of testing. AMS does 

not have the statutory authority to 

institute this type of third-party funding 

model. 

Purpose of Testing—Changes Requested 

But Not Made 

AMS received several comments 

requesting clarification on the purpose 

of residue testing. 

AMS is publishing this final rule to 

implement the requirements of the 

OFPA for periodic residue testing by 

certifying agents. Residue testing plays 

an important role in organic 

certification by providing a means for 

monitoring compliance with the NOP 

regulations and by discouraging the 

mislabeling of agricultural products. 

AMS does not intend to integrate 

results into a single dataset, as was 

requested by some commenters. To 

minimize the reporting burden for 

certifying agents, this final rule does not 

require that certifying agents submit 

copies of test results to the 

Administrator; however, certifying 

agents continue to be required to report 

certain test results that are found in 

excess of federal regulatory tolerances or 

action levels for pesticide residues or 

environmental contaminants to the 

appropriate health agency under the 

section 205.670(g). This final rule does 

not require reporting of testing data to 

the Administrator since this action is 

not intended as a data collection 

mechanism to draw conclusions about 

residues in organic products in general. 

AMS will verify compliance of 

certifying agents with this rule under 

the existing requirements for 

accreditation as discussed in the 

response to comments on Reporting 

Requirements. 

The NOP also notes that this final rule 

does not amend the existing 

requirement that results of all analyses 

and tests performed under section 

205.670 be made available for public 

access, unless the testing is part of an 

ongoing compliance investigation. The 

public may access sampling results 

obtained by certifying agents under the 

existing regulations. 

Types of Residues—Changes Requested 

But Not Made 

AMS received four comments 

regarding types of residues that would 

be considered acceptable targets for 

testing under the rule. 

On February 2, 2011, the NOP 

published NOP 2611–1, Prohibited 

Pesticides for NOP Residue Testing, on 

the NOP Web site in the NOP 

Handbook. This document provides a 

list of target pesticides to certifying 

agents that conduct pesticide residue 

testing of organically produced 

agricultural products. This document is 

available at the NOP Web site at 

http://www.ams.usda.gov/nop and is 

discussed below under Related 

Documents. AMS has not included a 

specific list of pesticide residues that 

could be tested for in the regulations. 

This is intended to allow flexibility in 

revising the list of target pesticide 

residues as new pesticides enter the 

market. In addition, this flexibility 

allows the NOP to respond more quickly 

to observed trends in detection of 

residues on specific commodities. 

The NOP does not intend for 

certifying agents to test every sample for 

all residues on the list of target 

pesticides. Instead, the list is provided 

as a reference for a number of pesticides 

which are prohibited under the NOP 

regulations, and that may be detected by 

a laboratory that conducts multi-residue 

analysis of agricultural products. 

AMS received one comment that 

indicated that this list would serve as a 

‘‘cheat sheet’’ for operations seeking to 

willfully violate the NOP regulations. 

AMS disagrees. The document provides 

a list of pesticide residues most 

commonly found on conventional 

commodities, based on data obtained 

from the AMS Pesticide Data Program. 

This list is intended to instruct 

certifying agents and laboratories on 

which residues would be the most 

useful targets for multi-residue analysis 

of agricultural products. The regulations 

and guidance documents do not 

prohibit a certifying agent from testing 

for other residues if the presence of a 

specific pesticide is suspected. 

Four commenters requested 

clarification on testing for genetically 

modified organisms (GMOs). AMS does 

not intend for the testing conducted 

under section 205.670 to be limited to 

pesticides residues. Under the existing 

provisions at section 205.670, certifying 

agents have the flexibility to test for a 

range of prohibited materials and 

excluded methods, including, but not 

limited to, pesticides, hormones, 

antibiotics, and GMOs. AMS notes that, 

under section 205.671, thresholds for 

unavoidable residual environmental 

contamination are established only for 

pesticides residues. 

Testing Methodology 

The final rule maintains the current 

requirement under section 205.670 that 

chemical analysis must be made in 

accordance with the methods described 

in the most current edition of the 

Official Methods of Analysis of the 

AOAC International 5 or other current 

applicable validated methodology for 

determining the presence of 

contaminants in agricultural products. 

On February 2, 2011, the NOP provided 

instructions on laboratory selection 

criteria for pesticide residue testing to 

certifying agents. These instructions are 

further described below under Related 

Documents and are available on the 

NOP Web site at http://www.ams.usda.

gov/nop. AMS anticipates that these 

instructions will change over time in 

response to advances in testing 

methodology, analytical 

instrumentation, and residue detection 

techniques. 

AMS received several comments 

regarding ISO 17025 accreditation of 

laboratories. This accreditation is 

mentioned in NOP 2611, Laboratory 

Selection Criteria for Pesticide Residue 

Testing, which is further discussed 

under Related Documents and is 

available on the NOP Web site at 

http://www.ams.usda.gov/nop. No 

comments requested the incorporation 

of ISO 17025 accreditation into the 

regulatory text. The comments are under 

consideration for future revision of the 

instruction documents and are not 

impacted by this rulemaking action. 

Information Collection Burden 

The proposed rule requested 

comments on the information collection 

and recordkeeping requirements 

required by the proposed amendments 

to section 205.670. Comments were 

specifically invited on (1) whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

AMS received four comments 

specifically on the issue of information 

collection burden. Two comments 

indicated that they were unclear 

whether the estimated time is accurate 

and that more data and analysis was 

needed. One commenter suggested that 

the NOSB should hear from the various 

stakeholders in public forums before 

AMS considers the accuracy of the 

estimate. One commenter indicated that 

the estimate of 1.74 hours appears to be 


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March 2010. Available at http://www.usda.gov/oig/ 

webdocs/01601-03-HY.pdf. 

low, especially when foreign operations 

and imported products are considered, 

but did not offer an alternative estimate 

for the number of hours or data to 

support a different estimate. 

Two comments indicated that 

submission of report copies, or 

laboratory summaries of test results, 

should be sufficient to demonstrate 

compliance with the requirement. In 

order to reduce the information 

collection burden on certifying agents, 

AMS has removed the requirement that 

test results be reported to the 

Administrator. AMS has retained the 

requirement that test results that 

indicate a specific agricultural product 

contains pesticide residues or 

environmental contaminants that 

exceed the Food and Drug 

Administration’s or the Environmental 

Protection Agency’s regulatory 

tolerances be reported to the appropriate 

health agency. 

AMS intends to verify compliance of 

certifying agents with the requirements 

for periodic residue testing as part of the 

existing accreditation process, rather 

than by requiring submission of residue 

testing results. Accreditation 

requirements at section 205.504(b)(6) 

require certifying agents to have 

administrative policies and procedures, 

including procedures to be used for 

sampling and residue testing pursuant 

to § 205.670. Certifying agents are also 

required to submit an annual report to 

the Administrator on or before the 

anniversary date of the issuance of 

notification of accreditation which 

includes a complete and accurate 

update of information submitted 

pursuant to §§ 205.503 and 205.504. In 

order to verify that certifying agents are 

implementing this rule in advance of 

regularly scheduled on-site audit of 

certifying agents, AMS intends to 

require, as authorized under section 

205.510(a)(3), certifying agents to 

submit in their next annual report a 

description of the measures 

implemented in the previous year and 

any measures to be implemented in the 

coming years to meet the requirements 

in this rule for periodic residue testing. 

AMS received one comment that 

indicated that the proposed rule did not 

identify what would be done with the 

information collected. A response is 

provided above under the section, 

Purpose of Testing—Changes Requested 

But Not Made. 

One comment suggested that existing 

testing programs, such as the AMS 

Pesticide Data Program, should be used 

to the extent possible. The commenter 

also suggested that AMS should partner 

with the FDA and various State agencies 

that currently conduct residue testing 

programs. AMS notes that testing 

conducted by other third-parties does 

not eliminate the requirement under 

OFPA for residue testing by certifying 

agents. AMS believes that requiring 

certifying agents to conduct residue 

testing from a minimum of five percent 

of the operations they certify is a 

reasonable number which ensures that 

all certifying agents, regardless of the 

number of operations they certify, are 

responsible for some level of regular 

testing at reasonable cost. 

One comment indicated that 

certifying agents would prefer to submit 

test results on a quarterly basis. In this 

final rule, AMS has removed the 

requirement for reporting results of 

residue testing, with the exception of 

results that exceed certain federal 

regulatory requirements established by 

EPA or FDA. AMS notes that certifying 

agents should maintain the complete 

results of laboratory analyses for 

residues of pesticides and other 

prohibited substances conducted during 

the current and three preceding 

calendar years, as required by section 

205.504(b)(5)(iii). 

Comments on Instruction Documents 

AMS received four comments on 

instruction documents that the NOP has 

published in the NOP Handbook 

regarding residue testing. The 

instruction documents are discussed 

under Related Documents. These 

comments are beyond the scope of this 

rulemaking; however, they are under 

consideration for future revision of the 

instruction documents through a 

separate action. 

III. Related Documents 

A proposed rule was published in the 

Federal Register on April 29, 2011 (76 

FR 23914). Additional documents 

related to this final rule include the 

Organic Foods Production Act (OFPA), 

as amended (7 U.S.C. 6501–6522) and 

its implementing regulations (7 CFR 

part 205). The March 2010 USDA Office 

of Inspector General audit report of the 

National Organic Program is available as 

Audit Report 01601–03–Hy.6

The NOP has also published three 

instruction documents related to residue 

testing as part of the NOP Handbook: (1) 

Sampling Procedures for Residue 

Testing (NOP 2610), (2) Laboratory 

Selection Criteria for Pesticide Residue 

Testing (NOP 2611), and (3) Prohibited 

Pesticides for NOP Residue Testing 

(NOP 2611–1). The goal of the NOP 

Handbook is to provide those who own, 

manage, or certify organic operations 

with guidance, instructions, and policy 

memos that can assist them in 

complying with the NOP regulations. 

The most recent edition of the NOP 

Handbook is available for viewing and 

downloading through the NOP Web site 

at http://www.ams.usda.gov/nop. 

The three instruction documents are 

meant to inform certifying agents about 

best practices for conducting residue 

testing of organically produced 

agricultural products. NOP 2610, 

Sampling Procedures for Residue 

Testing, contains recommended 

procedures for product sampling, 

including documentation, 

recommended sample sizes, shipping 

conditions to the laboratory, and chain 

of custody requirements. NOP 2611, 

Laboratory Selection Criteria for 

Pesticide Residue Testing, contains 

instructions for certifying agents in 

selecting a qualified laboratory for 

pesticide residue testing, including 

accreditation, quality assurance, 

proficiency testing, and reporting 

guidelines. NOP 2611–1, Prohibited 

Pesticides for NOP Residue Testing, is a 

list of pesticide residues that certifying 

agents can provide to laboratories which 

conduct pesticide residue testing of 

agricultural products. The three 

instruction documents were effective 

immediately upon their issuance and 

publication on February 2, 2011. 

On June 13, 2011, the NOP published 

draft guidance, NOP 5028—Responding 

to Results from Pesticide Residue 

Testing, that outlines the actions to be 

taken by accredited certifying agents if 

test results from residue analysis show 

evidence of prohibited substance(s) in 

or on the product. A notice on the 

availability of draft guidance was 

published in the Federal Register (76 

FR 34180) with a 60 day comment 

period. The comment period closed on 

August 12, 2011, and comments are 

under review by the NOP. After review 

of the comments received, the NOP 

intends to publish the final guidance in 

the NOP Handbook. 

Members of the public who wish to 

request that the agency issue, 

reconsider, modify, or rescind a 

guidance or instruction document may 

do so by sending an email to 

NOP.Guidance@ams.usda.gov or by 

mailing a letter to Standards Division, 

National Organic Program, U.S. 

Department of Agriculture, Room 2646- 

So. (Stop 0268), 1400 Independence 

Ave. SW., Washington, DC 20250–0268. 

IV. Statutory and Regulatory Authority 

OFPA authorizes AMS to administer 

the NOP. Under the NOP, AMS oversees 

national standards for the production 


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Safety Violations, revised October 31, 2011. 

Available at http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5088951. 

8U.S. Department of Agriculture, Office of 

Inspector General, Audit Report 01601–03-Hy, 

March 2010. Available at http://www.usda.gov/oig/ 

webdocs/01601-03-HY.pdf. 

9U.S. Department of Agriculture, Office of 

Inspector General, Audit Report 01601–03-Hy, 

March 2010. Available at http://www.usda.gov/oig/ 

webdocs/01601-03-HY.pdf. 

and handling of organically produced 

agricultural products. 

Section 6506 of the OFPA requires 

periodic residue testing by certifying 

agents of agricultural products that have 

been produced on certified organic 

farms and handled through certified 

organic handling operations to 

determine whether such products 

contain any pesticide or other 

nonorganic residue or natural toxicants. 

This section also requires certifying 

agents to report violations of applicable 

laws relating to other federal tolerance 

requirements (e.g., pesticide residues in 

excess of FDA action levels or EPA 

tolerances) to the appropriate health 

agencies. Additional information on 

reporting health and safety violations 

has been previously provided by the 

NOP to stakeholders and interested 

parties.7 This information is available 

on the NOP Web site at http://www.ams.

usda.gov/nop. 

Section 6511 of the OFPA requires the 

Secretary, the applicable governing 

State official, and the certifying agent to 

utilize a system of residue testing to test 

products sold or labeled as organically 

produced. 

Section 6511 of the OFPA also allows 

the Secretary, the applicable governing 

State official, or the certifying agent to 

require preharvest tissue testing of any 

crop grown on soil suspected of 

harboring contaminants. 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This action 

has been determined not significant for 

purposes of Executive Order 12866, and 

therefore, has not been reviewed by the 

Office of Management and Budget. 

Need for the Rule 

NOP is authorized to implement 

regulations that require accredited 

certifying agents to conduct residue 

testing of organically produced 

agricultural products (7 U.S.C. 6511). In 

addition, section 6506 of the OFPA 

requires that the NOP include 

provisions for periodic residue testing 

by certifying agents of agricultural 

products produced or handled in 

accordance with the NOP. This final 

rule ensures that all certifying agents 

conduct a minimal level of residue 

testing. 

Residue testing plays an important 

role in organic certification by providing 

a means for monitoring compliance with 

the NOP and by discouraging the 

mislabeling of agricultural products. 

Testing of organically produced 

agricultural products is promulgated in 

section 205.670 of the NOP regulations. 

This section provides that the Secretary, 

State organic programs, and certifying 

agents may require preharvest or 

postharvest testing of any agricultural 

input used or agricultural product to be 

sold, labeled, or represented as ‘‘100 

percent organic,’’ ‘‘organic,’’ or ‘‘made 

with organic (specified ingredients or 

food group(s))’’ when there is reason to 

believe that the agricultural input or 

product has come into contact with a 

prohibited substance or has been 

produced using excluded methods. 

AMS is issuing this final rule in 

response to an audit of the NOP which 

was conducted in March 2010 by the 

USDA’s OIG.8 As part of the audit, the 

OIG visited four certifying agents 

accredited by the NOP. The OIG 

indicated that these certifying agents 

noted that they considered residue 

testing to be required by the regulations 

only under certain circumstances. 

AMS conducted a review of this issue 

in response to the OIG audit. AMS 

concluded that, under 7 U.S.C. section 

6506 of the OFPA, accredited certifying 

agents are required to conduct residue 

testing of organic products on a regular 

and reoccurring basis, as well as when 

there is reason to believe contamination 

has occurred. 

Regulatory Objective 

The primary objective of this rule is 

to align the NOP regulations with the 

requirement for residue testing of 

organic products under OFPA. This 

final rule ensures that all certifying 

agents conduct a minimum level of 

residue testing. 

Alternatives Considered 

Alternatives to this final rule that 

were considered include (1) maintaining 

the status quo; (2) distinguishing 

periodic residue testing from risk-based 

testing for purposes of calculating the 

percentage of operations to be tested 

annually; (3) requiring testing at an 

alternate level of 25% of the operations 

certified by a certifying agent; and (4) 

testing all certified operations annually. 

In addition, proposals for testing at a 

reduced sampling rate, and testing 

scaled to the size of operation or to the 

number of certified organic products 

were suggested by commenters and are 

discussed under the above section, 

Number of Samples—Changes 

Requested But Not Made. AMS believes 

that calculating the samples based on a 

percentage of operations reduces the 

burden on the certifying agents by 

providing a clear and simple formula for 

how to comply with the regulations. 

AMS has not specified how certifying 

agents must select operations for residue 

testing to provide flexibility and 

discretion to the certifying agent in how 

to most efficiency and effectively 

implement the minimum testing 

required under the rule. Operation 

selection for residue testing may include 

risk factors such as number of products 

produced, split operations, size of the 

operation, split operations (i.e., 

operations that produce or handle both 

organic and nonorganic agricultural 

products), previous non-compliances, 

high-value or high-risk crops, or other 

criteria deemed appropriate by the 

certifying agent. 

The first alternative of maintaining 

the status quo was not considered 

feasible due to a finding identified in an 

audit report issued by USDA’s OIG in 

March 2010.9 In response to the OIG 

audit, AMS conducted a review of the 

residue testing requirements in OFPA 

and the NOP regulations. AMS 

concluded that, under section 6506 of 

the OFPA, accredited certifying agents 

are required to conduct residue testing 

of organic products on a regular and 

reoccurring basis, as well as when there 

is reason to believe contamination has 

occurred, and that the regulations be 

revised as provided for in this 

rulemaking. 

The second alternative distinguishes 

between periodic residue testing and 

risk-based testing for purposes of 

calculating the percentage of operations 

to be tested annually. This alternative 

was discussed in the proposed rule 

published April 29, 2011 (76 FR 23914). 

The proposed rule indicated that 

certifying agents would need to sample 

a minimum of five percent of their 

certified operations annually, and that 

such testing would be in addition to any 

testing conducted when there was 


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May 2010. http://bls.gov/oes/current/ 

oes452011.htm. 

reason to believe that the agricultural 

product had come into contact with a 

prohibited substance (e.g., investigative 

or complaint-driven testing). This 

alternative would result in higher costs 

to the certifying agent, since costs 

associated with other types of testing 

would be in addition to costs for 

periodic testing. After consideration of 

the comments received, AMS believes 

that the final rule offers more flexibility 

by allowing both complaint-driven and 

periodic residue testing to count toward 

the sample minimum. This final rule 

should also minimize the burden on 

certifying agents by removing the need 

to distinguish between different types of 

testing. 

The third alternative of requiring 

certifying agents to test 25% of the 

operations they certify annually was 

also considered. This target is based a 

statistically based sample size based 

upon the rate of detection of residues in 

organic products sampled through the 

AMS Pesticide Data Program (PDP). The 

costs associated with this alternative 

and that would be imposed on certifying 

agents are estimated at $3.70 million 

annually, based on an estimated $492 in 

costs to the certifying agent per 

operation tested across 7,530 certified 

operations (25% of 30,118). The costs 

associated with testing 25% of 

operations are significantly higher than 

the costs of sampling 5% of operations 

under the final rule. AMS determined 

that using a statistically based sample 

size is not necessary to achieve the 

regulatory objective of this action and 

would impose unnecessary additional 

direct costs to certifying agents. 

The fourth alternative of sampling all 

operations annually was also considered 

as an alternative to the five percent 

minimum requirement. The costs 

associated with this alternative are 

estimated at $14.82 million annually, 

based on an estimated $492 in costs per 

operation for 30,118 certified 

operations. The objectives for periodic 

residue testing can be met by sampling 

a subset of operations annually, and 

therefore, the additional costs that 

would be required to test all operations 

are unnecessary. 

Baseline 

AMS is aware that a minority of 

accredited certifying agents are 

currently conducting periodic residue 

testing at or above the minimum levels 

established by this final rule. In 2011, 

the NOP received pesticide residue 

results from 13 accredited certifying 

agents. Seven of the certifying agents 

that reported results to the NOP were 

based in the United States and six were 

based internationally. The NOP also 

understands that there may be 

additional certifying agents that are 

currently conducting residue testing 

that do not report results to the NOP, or 

that submit results only when a 

prohibited residue is detected. 

The number of results reported to the 

NOP in 2011 represents a sampling rate 

of less than 1% of certified operations. 

The majority of results reported to the 

NOP in 2011 were received from 

certifying agents which are 

headquartered outside of the United 

States, where periodic residue testing is 

a requirement under international 

organic standards (e.g., the EU). AMS 

received one comment on the proposed 

rule from a certifying agent operating 

outside of the United States which 

indicates that it currently tests 20–25% 

of its certified operations. 

AMS received one comment from a 

certifying agent that indicated that it has 

a history of sampling and testing 

products for more than 20 years. This 

commenter supported the five percent 

testing requirement as outlined in the 

proposed rule and did not support 

revising the rule to include compliance 

or investigative testing as part of the five 

percent. AMS also received one 

comment from a certifying agent that 

had increased their testing program for 

residues within the last two years and 

requested that the proposed rule be 

revised to allow sampling from sources 

other than the agricultural product (e.g. 

samples of soil, water, seeds) to be 

counted towards the minimum testing 

requirement. Under this final rule, 

sampling from a range of sources as 

indicated in sections 205.670(b) and (c) 

may be counted towards the minimum 

testing requirement. 

Benefits to the Final Rule 

This final rule clarifies a provision of 

OFPA and the regulations issued 

thereunder that requires periodic 

residue testing of organically produced 

agricultural products by accredited 

certifying agents. The rule ensures 

consistency of the regulations with 

OFPA by ensuring that all certifying 

agents are conducting residue testing of 

organic products on a regular 

reoccurring basis. Residue testing plays 

an important role in organic 

certification by providing a means for 

monitoring compliance with the NOP 

and by discouraging the mislabeling of 

agricultural products. This action 

further ensures the integrity of products 

produced and handled under the NOP 

regulations. 

Costs of the Final Rule 

This final rule increases the amount 

of residue testing currently conducted 

by most accredited certifying agents. 

Direct costs to the certifying agents 

include the cost of sample analysis (i.e., 

laboratory costs), sample packaging and 

shipping costs, and the staff costs 

associated with sample collection by an 

inspector, review and maintenance of 

sample results, and reporting costs. In 

addition, some certifying agents 

indicated that the proposed action 

would also increase their training costs 

for review staff and field inspectors. 

AMS is unable to ascertain how 

certification fees may shift in response 

to this action because of the diversity of 

fee structures used by certifying agents. 

The total direct cost of this action is 

estimated to be $741,000 annually. This 

estimate is based on a sampling rate of 

five percent of certified operations. 

There were an estimated 30,118 

operations certified under the NOP in 

2011. The five percent sampling 

requirement would result in sample 

collection from approximately 1,506 

operations per year. AMS has estimated 

the total costs to the certifying agent at 

$492 per sample as detailed in Table 1. 

Sample collection costs (inspector 

costs) are estimated at $20.36 per 

sample. This estimate is based on an 

estimated 1.0 labor hour per sample at 

$20.36 per hour. The hourly rate is 

estimated based on the mean hourly 

wage for agricultural inspectors as 

published by the Bureau of Labor 

Statistics.10 This classification was 

selected as an occupation with similar 

duties and responsibilities to that of an 

organic inspector. Such duties and 

responsibilities include inspection of 

agricultural commodities, processing 

equipment, and facilities, to ensure 

compliance with regulations and laws 

governing health, quality, and safety. 

Sample shipping boxes and supplies 

are estimated at $40 per sample, based 

on a costs associated with a pilot project 

for pesticide residue sampling 

conducted by the NOP in conjunction 

with the AMS Pesticide Data Program. 

Shipping costs are estimated at $25 per 

sample. AMS notes that these costs are 

an average and may vary depending on 

the sample type and shipping distance 

to laboratory. 

Labor costs associated with review of 

sample results are estimated at $16.21 

per sample. This estimate is based on an 

estimated 0.5 labor hour per sample at 

$32.42 per hour. The hourly rate is 

estimated based on the mean hourly 

wage for auditors as published by the 


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67248 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 

11U.S. Department of Labor, Bureau of Labor 

Statistics, Occupational Employment and Wages, 

May 2009. http://www.bls.gov/oes/2009/may/ 

oes132011.htm. 

Bureau of Labor Statistics.11 This 

classification was selected as an 

occupation with similar duties and 

responsibilities to that of a certifying 

agent. Such duties and responsibilities 

include conducting reviews of 

operations against accepted standards 

and evaluating audit or inspection 

findings for compliance. 

If certifying agents receive sample 

results which are in excess of EPA or 

FDA regulatory tolerances, the certifying 

agent must promptly report such data to 

the Federal health agency (i.e., EPA or 

FDA) whose regulatory tolerance or 

action level has been exceeded. Test 

results that exceed federal regulatory 

tolerances must also be reported to the 

appropriate State health agency or 

foreign equivalent. This requirement is 

clarified in this final rule under 

§ 205.670(g); however, this is not a new 

requirement under this action and 

additional costs not expected from this 

clarification. AMS expects that the 

majority of tested organic products will 

not have detectable residues of 

prohibited pesticide substances, based 

on historical data from the AMS 

Pesticide Data Program. 

AMS believes that this rate of testing 

provides the benefits at reasonable cost 

to certifying agents. AMS recognizes 

that a minority of certifying agents 

conduct residue testing on a regular 

basis, and that certifying agents not 

currently conducting testing will need 

to account for these costs as a cost of 

doing business. 

In consideration of training costs, the 

NOP notes that, while this action 

expands the amount of testing of 

organically produced agricultural 

products to include a requirement that 

is regular and periodic in scope, 

certifying agents are already required, 

under section 205.504(b)(6), to have 

procedures in place for sampling and 

residue testing pursuant to section 

205.670. Certifying agents must already 

be conducting sampling and laboratory 

testing in instances where 

contamination is suspected under 

section 205.403(c)(3) and section 

205.670(b). Therefore, AMS does not 

believe that additional training costs are 

imposed by this final rule. 

TABLE 1—ESTIMATED COSTS PER SAMPLE COLLECTED

Item Estimated cost 

per sample Basis for estimate 

Sample collection (inspector time) ............ $20.36 1 hour @ $20.36 per hour. 

Sample shipping boxes and supplies ....... 40.00 AMS Pesticide Data Program. 

Shipping costs .......................................... 25.00 Estimate for in-state shipping of 5 pound sample. 

Laboratory costs for multi-residue analysis.390.00 AMS Pesticide Data Program. 

Review of Sample Results—Labor Costs 16.21 0.5 hour @ $32.42 per hour. 

Total costs per sample ...................... 491.57 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This final rule is not intended to have 

a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in section 

6514(b) of the OFPA. States are also 

preempted under sections 6503 through 

6507 of the OFPA from creating 

certification programs to certify organic 

farms or handling operations unless the 

State programs have been submitted to, 

and approved by, the Secretary as 

meeting the requirements of the OFPA. 

Pursuant to section 6507 of the OFPA, 

a State organic certification program 

may contain additional requirements for 

the production and handling of 

organically produced agricultural 

products that are produced in the State 

and for the certification of organic farm 

and handling operations located within 

the State under certain circumstances. 

Such additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to section 6519 of the OFPA, 

this final rule would not alter the 

authority of the Secretary under the 

Federal Meat Inspection Act (21 U.S.C. 

601–624), the Poultry Products 

Inspection Act (21 U.S.C. 451–471), or 

the Egg Products Inspection Act (21 

U.S.C. 1031–1056), concerning meat, 

poultry, and egg products, nor any of 

the authorities of the Secretary of Health 

and Human Services under the Federal 

Food, Drug and Cosmetic Act (21 U.S.C. 

301–392), nor the authority of the 

Administrator of the EPA under the 

Federal Insecticide, Fungicide and 

Rodenticide Act (7 U.S.C. 136–136(y)). 

Section 6520 of the OFPA provides 

for the Secretary to establish an 

expedited administrative appeals 

procedure under which persons may 

appeal an action of the Secretary, the 

applicable governing State official, or a 

certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. district court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Executive Order 13175 

This final rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this regulation will not have substantial 

and direct effects on Tribal governments 

and will not have significant Tribal 

implications. 

D. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) requires agencies to 

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 


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Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 67249 

12U.S. Department of Agriculture, Economic 

Research Service. 2009. Data Sets: U.S. Certified 

Organic Farmland Acreage, Livestock Numbers and 

Farm Operations, 1992–2008. http:// 

www.ers.usda.gov/Data/Organic/. 

13U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers: Documentation. 

http://www.ers.usda.gov/Data/OrganicHandlers/ 

Documentation.htm. 

14As reported by certifying agents during the 

2010 certification year and available at http:// 

apps.ams.usda.gov/nop/. 

15 Dimitri, C.; Oberholtzer, L. 2009. Marketing 

U.S. Organic Foods: Recent Trends from Farms to 

Consumers, Economic Information Bulletin No. 58, 

U.S. Department of Agriculture, Economic Research 

Service, http://www.ers.usda.gov/Publications/ 

EIB58. 

16Organic Trade Association’s 2011 Organic 

Industry Survey, http://www.ota.com. 

barriers that would restrict their ability 

to compete in the market. The purpose 

of the RFA is to fit regulatory actions to 

the scale of businesses subject to such 

actions in order that small business will 

not be unduly or disproportionately 

burdened. Section 605 of RFA allows an 

agency to certify a rule, in lieu of 

preparing an analysis, if the rulemaking 

is not expected to have a significant 

economic impact on a substantial 

number of small entities. 

Pursuant to the requirements set force 

in the RFA, AMS performed an 

economic impact analysis on small 

entities in the final rule published in the 

Federal Register on December 21, 2000 

(65 FR 80548). AMS has also considered 

the economic impact of this final rule 

on small entities. AMS certifies that this 

rule would not have a significant 

economic impact on a substantial 

number of small entities. 

Small agricultural service firms, 

which include producers, handlers, and 

accredited certifying agents, have been 

defined by the Small Business 

Administration (SBA) (13 CFR 121.201) 

as those having annual receipts of less 

than $7,000,000 and small agricultural 

producers are defined as those having 

annual receipts of less than $750,000. 

According to Economic Research 

Service (ERS) data, based on 

information from USDA accredited 

certifying agents, the number of certified 

U.S. organic crop and livestock 

operations totaled nearly 13,000 and 

certified organic acreage exceeded 4.8 

million acres in 2008.12 ERS, based 

upon the list of certified operations 

maintained by the NOP, estimated the 

number of certified handling operations 

was 3,225 in 2007.13 AMS estimates that 

there were 30,118 operations certified to 

the NOP in 2011. USDA has 93 

accredited certifying agents that provide 

certification services to producers and 

handlers under the NOP. A complete 

list of names and addresses of certifying 

agents may be found on the AMS NOP 

Web site at: http://www.ams.usda.gov/ 

nop. AMS believes that most of these 

entities would be considered small 

entities under the criteria established by 

the SBA. 

This final rule will affect all certifying 

agents by requiring that each agent 

conduct residue testing from a 

minimum of five percent of the 

operations they certify on an annual 

basis. This level was chosen to ensure 

that all certifying agents, regardless of 

the number of operations they certify, 

are responsible for some level of regular 

residue testing at reasonable cost. Under 

section 205.670, certifying agents have 

been responsible for expenses 

associated with preharvest and 

postharvest testing; this requirement 

also applies to expenses for periodic 

residue testing in this final rule. To 

estimate the annual costs associated 

with instituting periodic residue testing, 

the NOP conducted a preliminary 

assessment of costs at different 

minimum testing requirements (i.e., 5%, 

25%, and 100% of certified operations). 

Under this new action with a five 

percent minimum testing requirement, 

the two certifying agents with the largest 

number of certified operations 

(approximately 2,100 operations each in 

2009) are required to collect a minimum 

of 105 samples. Smaller certifying 

agents (those certifying fewer than 30 

operations) are required to collect and 

test at least 1 sample on an annual basis. 

In 2010, approximately one-third of 

accredited certifying agents certified 

fewer than 30 operations to the NOP.14

Over half of all certifying agents 

certified fewer than 200 operations in 

2010 and are required to sample 10 or 

fewer operations annually under this 

final rule. 

At a five percent minimum testing 

requirement, the costs of sampling are 

estimated from approximately $492 to 

51,106 per certifying agent per year 

based on the average cost of $492 per 

sample and the range in the number of 

operations certified by different 

certifying agents. Additional costs may 

be required to follow up on results if 

prohibited substances are detected. 

AMS expects that the majority of results 

will be for samples with no prohibited 

residues detected, based on historical 

data from the AMS Pesticide Data 

Program. 

AMS is establishing a five percent 

testing level in this final rule because 

this level is expected to be, in most 

cases, no more than two percent of a 

given certifying agent’s operating 

budget, a level that can be considered a 

reasonable cost to the organic industry 

given the benefits of residue testing in 

discouraging the mislabeling of 

agricultural products. Furthermore, the 

number of samples required at a five 

percent level is consistent with the 

amount of residue sampling already 

being conducted by some certifying 

agents. As a percentage of a certifying 

agent’s total operating costs, this 

estimate was revised upward from one 

percent to two percent, based on public 

comment received in response to the 

proposed rule. Comments included a 

summary of data from an association 

representing certifying agents, and 

included data from 25 certifying agents. 

The range of costs was reported at 

between 1% and 11% of a certifying 

agent’s overall operating budget, with 

one certifying agent reporting that the 

cost of one sample would account for 

11% of their total operating costs for the 

year and one certifying agent reporting 

that the cost for three samples would 

account for 1% of their total operating 

costs. The majority of these certifying 

agents estimated the costs associated 

with this action to account for no more 

than 2% of their operating budget 

annually. 

Alternatives to this final rule that 

were considered include (1) maintaining 

the status quo; (2) distinguishing 

periodic residue testing from risk-based 

testing for purposes of calculating the 

percentage of operations to be tested 

annually; (3) requiring testing at an 

alternate level of 25% of the operations 

certified by a certifying agent; and (4) 

testing all certified operations annually. 

These are discussed in detail above 

under Alternatives Considered. AMS 

determined that the alternatives of a 

statistically based sample size (i.e., 25% 

of operations annually) or testing all 

operations annually were not practical 

due to the costs and the uneven burden 

that could be placed upon smaller 

certifying agents in either scenario. 

The U.S. sales of organic food and 

beverages have grown from $3.6 billion 

in 1997 to nearly $21.1 billion in 

2008.15 Between 1990 and 2008, organic 

food sales have historically 

demonstrated a growth rate between 15 

to 24 percent each year. In 2010, organic 

food sales grew 7.7%.16

The NOP is authorized under OFPA 

to implement regulations that require 

accredited certifying agents to conduct 

residue testing of organically produced 

agricultural products (7 U.S.C. § 6511). 

In addition, the OFPA requires that the 

NOP include provisions for periodic 

residue testing by certifying agents of 

agricultural products produced or 

handled in accordance with the NOP (7 


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67250 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 

U.S.C. § 6506). This final rule ensures 

that all certifying agents conduct a 

minimal level of residue testing. 

Residue testing plays an important 

role in organic certification by providing 

a means for monitoring compliance with 

the NOP and by discouraging the 

mislabeling of agricultural products. 

Testing of organically produced 

agricultural products is promulgated in 

section 205.670 of the NOP regulations. 

This section provides that the Secretary, 

State organic programs, and certifying 

agents may require preharvest or 

postharvest testing of any agricultural 

input used or agricultural product to be 

sold, labeled, or represented as ‘‘100 

percent organic,’’ ‘‘organic,’’ or ‘‘made 

with organic (specified ingredients or 

food group(s))’’ when there is reason to 

believe that the agricultural input or 

product has come into contact with a 

prohibited substance or has been 

produced using excluded methods. 

However, AMS has concluded that, 

under 7 U.S.C. § 6506 of the OFPA, 

accredited certifying agents are required 

to conduct residue testing of organic 

products on a regular and reoccurring 

basis, as well as when there is reason to 

believe contamination has occurred. 

The final rule is necessary to clarify 

a requirement of OFPA that certifying 

agents conduct periodic residue testing 

of organic products. The final rule will 

increase the amount of residue testing 

that certifying agents must conduct 

when compared to the current 

regulations. This final rule ensures that 

certifying agents are conducting a 

minimal level of residue testing on a 

regular and reoccurring basis. 

The cost of testing is to be borne by 

the applicable certifying agent and is 

considered a cost of doing business. 

The population that is directly 

impacted by this final rule is accredited 

certifying agents. The USDA has 93 

certifying agents who provide 

certification services to producers and 

handlers under the NOP. A complete 

list of names and addresses of certifying 

agents may be found on the AMS NOP 

Web site at: http://www.ams.usda.gov/ 

nop. AMS believes that most accredited 

certifying agents would be considered 

small entities under the criteria 

established by the SBA. Approximately 

30,118 operations worldwide were 

certified to the NOP standard in 2011; 

certified operations may be indirectly 

impacted by this action as additional 

operations will be subject to residue 

testing by certifying agents. 

For certifying agents who are not 

currently conducting residue testing at 

the minimum levels specified in the 

final rule, this action will increase costs. 

AMS has estimated costs at $492 per 

sample. At an estimated cost of $492 per 

sample and a sampling rate of 5% of 

certified operations, certifying agents 

would need to budget an estimated $25 

per certified operation for testing costs. 

The total costs of residue testing are 

estimated at approximately $492 to 

$51,106 per certifying agent per year 

based on the average cost of $492 per 

sample and the range in the number of 

operations certified by different 

certifying agents. Additional costs may 

be required to follow up on results if 

prohibited substances are detected. The 

portion of the total estimated costs 

would be considered new or additional 

costs as a result of this action is not 

known, as a minority of certifying 

agents are already conducting residue 

testing of organic products and have 

budgeted for these costs under their 

existing fee structures. If these costs 

have not been previously budgeted for 

by the certifying agent, it will need to 

account for these costs as part of their 

cost of business. 

To reduce additional inspector costs 

associated with sample collection, AMS 

has not specified which operations must 

be sampled annually or when the 

samples must be collected. This is 

intended to provide flexibility to the 

certifying agent implement a schedule 

for sample collection in the most 

efficient manner. 

The final rule will increase costs for 

certifying agents who are not currently 

performing residue testing at the 

minimal levels specified in this rule. 

Some certifying agents may increase 

their certification fees for its clients to 

pay for additional costs associated with 

residue testing. At an estimated cost of 

$492 per sample and a sampling rate of 

5% of certified operations, certifying 

agents would need to budget 

approximately $25 per operation for 

testing costs. 

This final rule clarifies a provision of 

OFPA and the regulations issued 

thereunder that requires periodic 

residue testing of organically produced 

agricultural products by accredited 

certifying agents. The final rule expands 

the amount of residue testing of 

organically produced agricultural 

products by clarifying that sampling and 

testing are required on a regular basis. 

The final rule requires that certifying 

agents, on an annual basis, sample and 

conduct residue testing from a 

minimum of five percent of the 

operations that they certify. 

AMS believes that the benefits of 

residue testing in protecting organic 

integrity and ensuring compliance with 

the regulations outweigh the estimated 

costs. 

E. Paperwork Reduction Act 

In accordance with Office of 

Management and Budget (OMB) 

regulations (5 CFR part 1320) that 

implement the Paperwork Reduction 

Act (44 U.S.C. 3501–3520) (PRA), the 

information collection requirements 

associated with the NOP have been 

previously approved by OMB and 

assigned OMB control number 0581– 

0191. A new information collection 

package was submitted to OMB at the 

proposed rule stage for approval of 776 

hours in total burden hours to cover this 

new collection and recordkeeping 

burden of the amendments to section 

205.670 of this final rule. Between the 

proposed rule and this final rule, there 

is a reduction of 350 hours based on 

comments received. Upon OMB’s 

approval of this new information 

collection, the NOP intends to merge 

this collection into currently approved 

OMB Control Number 0581–0191. 

AMS is committed to complying with 

the E-Government Act to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

F. Civil Rights Impact Analysis 

AMS has reviewed this rule in 

accordance with the Department 

Regulation 4300–4, Civil Rights Impact 

Analysis (CRIA), to address any major 

civil rights impacts the rule might have 

on minorities, women, and persons with 

disabilities. After a careful review of the 

rule’s intent and provisions, AMS has 

determined that this rule has no 

potential for affecting certified 

operations or certifying agents in 

protected groups differently than the 

general population of certified 

operations and certifying agents. This 

rulemaking was initiated to clarify a 

regulatory requirement and enable 

consistent implementation and 

enforcement. 

Protected individuals have the same 

opportunity to participate in the NOP as 

non-protected individuals. The NOP 

regulations prohibit discrimination by 

certifying agents. Specifically, section 

205.501(d) of the current regulations for 

accreditation of certifying agents 

provides that ‘‘No private or 

governmental entity accredited as a 

certifying agent under this subpart shall 

exclude from participation in or deny 

the benefits of the NOP to any person 

due to discrimination because of race, 

color, national origin, gender, religion, 

age, disability, political beliefs, sexual 

orientation, or marital or family status.’’ 

Section 205.501(a)(2) requires 


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Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Rules and Regulations 67251 

‘‘certifying agents to demonstrate the 

ability to fully comply with the 

requirements for accreditation set forth 

in this subpart’’ including the 

prohibition on discrimination. The 

granting of accreditation to certifying 

agents under section 205.506 requires 

the review of information submitted by 

the certifying agent and an on-site 

review of the certifying agent’s 

operation. Further, if certification is 

denied, section 205.405(d) requires that 

the certifying agent notify the applicant 

of their right to file an appeal to the 

AMS Administrator in accordance with 

section 205.681. These regulations 

provide protections against 

discrimination, thereby permitting all 

handlers, regardless of race, color, 

national origin, gender, religion, age, 

disability, political beliefs, sexual 

orientation, or marital or family status, 

who voluntarily choose to adhere to the 

final rule and qualify, to be certified as 

meeting NOP requirements by an 

accredited certifying agent. This final 

rule in no way changes any of these 

protections against discrimination. 

List of Subjects in 7 CFR Part 205 

Administrative practice and 

procedure, Agriculture, Animals, 

Archives and records, Imports, Labeling, 

Organically produced products, Plants, 

Reporting and recordkeeping 

requirements, Seals and insignia, Soil 

conservation. 

For the reasons set forth in the 

preamble, 7 CFR part 205 is amended as 

follows: 

PART 205—NATIONAL ORGANIC 

PROGRAM 

■ 1. The authority citation for 7 CFR 

part 205 continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

■ 2. Section 205.670 is revised to read 

as follows: 

§ 205.670 Inspection and testing of 

agricultural products to be sold or labeled 

as ‘‘100 percent organic,’’ ‘‘organic,’’ or 

‘‘made with organic (specified ingredients 

or food group(s)).’’ 

(a) All agricultural products that are 

to be sold, labeled, or represented as 

‘‘100 percent organic,’’ ‘‘organic,’’ or 

‘‘made with organic (specified 

ingredients or food group(s))’’ must be 

made accessible by certified organic 

production or handling operations for 

examination by the Administrator, the 

applicable State organic program’s 

governing State official, or the certifying 

agent. 

(b) The Administrator, applicable 

State organic program’s governing State 

official, or the certifying agent may 

require preharvest or postharvest testing 

of any agricultural input used or 

agricultural product to be sold, labeled, 

or represented as ‘‘100 percent organic,’’ 

‘‘organic,’’ or ‘‘made with organic 

(specified ingredients or food group(s))’’ 

when there is reason to believe that the 

agricultural input or product has come 

into contact with a prohibited substance 

or has been produced using excluded 

methods. Samples may include the 

collection and testing of soil; water; 

waste; seeds; plant tissue; and plant, 

animal, and processed products 

samples. Such tests must be conducted 

by the applicable State organic 

program’s governing State official or the 

certifying agent at the official’s or 

certifying agent’s own expense. 

(c) A certifying agent must conduct 

periodic residue testing of agricultural 

products to be sold, labeled, or 

represented as ‘‘100 percent organic,’’ 

‘‘organic,’’ or ‘‘made with organic 

(specified ingredients or food 

group(s)).’’ Samples may include the 

collection and testing of soil; water; 

waste; seeds; plant tissue; and plant, 

animal, and processed products 

samples. Such tests must be conducted 

by the certifying agent at the certifying 

agent’s own expense. 

(d) A certifying agent must, on an 

annual basis, sample and test from a 

minimum of five percent of the 

operations it certifies, rounded to the 

nearest whole number. A certifying 

agent that certifies fewer than thirty 

operations on an annual basis must 

sample and test from at least one 

operation annually. Tests conducted 

under paragraphs (b) and (c) of this 

section will apply to the minimum 

percentage of operations. 

(e) Sample collection pursuant to 

paragraphs (b) and (c) of this section 

must be performed by an inspector 

representing the Administrator, 

applicable State organic program’s 

governing State official, or certifying 

agent. Sample integrity must be 

maintained throughout the chain of 

custody, and residue testing must be 

performed in an accredited laboratory. 

Chemical analysis must be made in 

accordance with the methods described 

in the most current edition of the 

Official Methods of Analysis of the 

AOAC International or other current 

applicable validated methodology for 

determining the presence of 

contaminants in agricultural products. 

(f) Results of all analyses and tests 

performed under this section will be 

available for public access, unless the 

testing is part of an ongoing compliance 

investigation. 

(g) If test results indicate a specific 

agricultural product contains pesticide 

residues or environmental contaminants 

that exceed the Food and Drug 

Administration’s or the Environmental 

Protection Agency’s regulatory 

tolerances, the certifying agent must 

promptly report such data to the Federal 

health agency whose regulatory 

tolerance or action level has been 

exceeded. Test results that exceed 

federal regulatory tolerances must also 

be reported to the appropriate State 

health agency or foreign equivalent. 

Dated: November 5, 2012. 

David R. Shipman, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2012–27378 Filed 11–8–12; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. FAA–2012–1194; Special 

Conditions No. 25–472–SC] 

Special Conditions: Boeing Model 757 

Series Airplanes; Seats with NonTraditional, Large, Non-Metallic Panels 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special condition; request 

for comments. 

SUMMARY: These special conditions are 

issued for the Boeing Model 757 series 

airplanes. These airplanes as modified 

by Flight Structures, Inc. will have 

novel or unusual design features 

associated with seats that include nontraditional, large, non-metallic panels 

that would affect survivability during a 

post-crash fire event. The applicable 

airworthiness regulations do not contain 

adequate or appropriate safety standards 

for this design feature. These special 

conditions contain the additional safety 

standards that the Administrator 

considers necessary to establish a level 

of safety equivalent to that established 

by the existing airworthiness standards. 

DATES: The effective date of these 

special conditions is November 5, 2012. 

We must receive your comments by 

December 24, 2012. 

ADDRESSES: Send comments identified 

by docket number [FAA–2012–1194] 

using any of the following methods: 

• Federal eRegulations Portal: Go to 

http://www.regulations.gov/ and follow 

the online instructions for sending your 

comments electronically. 

Mail: Send comments to Docket 

Operations, M–30, U.S. Department of 

Transportation (DOT), 1200 New Jersey 


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